Repligen Corporation

QC Analyst

Job Locations TW-Taoyuan City
ID
2025-5207
Category
Quality
Type
Full-Time

Overview

This position is for a Quality Control Analyst, responsible for daily quality control activities, including routine testing, measurement, and analysis of products from both mass production and pilot production. The role also includes developing inspection methods for products and raw materials, or adopting methods developed by R&D. Additional responsibilities include planning and executing quality control plans, monitoring daily SPC results, managing nonconforming products, and supporting the root cause analysis for product quality issue.
(本職位為品質管制分析師,負責日常品質管制相關工作,包括例行的產品檢驗、測量與分析,涵蓋量產與試量產階段的產品。此職位亦包含產品與原物料檢驗方法的開發,或接收研發單位所制定的方法。此外,需規劃並執行品質管制計畫、每日監控統計製程管制(SPC)結果,並負責異常品的管制。

Responsibilities

  • Development and execution of incoming inspection methods for chemical substances and raw materials (化學藥品、原物料進料檢驗方法開發及執行)
  • Development and execution of quality inspection methods during the production process of polymers and ion exchange resins (高分子、離子交換樹脂製程中品質檢驗方法開發及執行)
  • Development and execution of final quality inspection methods for shipment of polymers and ion exchange resins (高分子、離子交換樹脂出貨品質檢驗方法開發及執行)
  • Daily monitoring of Statistical Process Control (SPC) results (監控統計製程管制(SPC)每日結果)
  • Planning and execution of Quality Control Plans (規劃並執行品質管制計畫(Quality Control Plan))
  • Nonconforming product control (異常品管制)
  • Supporting the root cause analysis for product quality issue (支援產品品質問題的根因調查)
  • Perform ad-hoc quality control activities, as required (根據需要執行特定的品質控制活動)
  • Involve or lead projects and assignments as part of the professional development opportunity (參與或領導專案和任務,作為專業發展機會的一部分)

Qualifications

  • Work Experience

More than 4 years(4年以上)

  • Education Requirements

Bachelor's or Master's degree(大學、碩士)

  • Preferred Fields of Study

Chemistry, Other Health and Medical Sciences, Chemical Engineering(化學相關,其他醫藥衛生相關,化學工程相關)

  • Language Requirements

English (Listening: Intermediate, Speaking: Intermediate, Reading: Intermediate, Writing: Intermediate) (英文(:中等、說:中等、讀:中等、寫:中等))

  • Proficient Tools

SPC (統計製程管制)

Quality Control Plan (品質管制計畫)

Six Sigma (六標準差)

  • Key Skills

Establishment of inspection standards for new products(制訂新產品檢驗標準)

Monitoring of raw materials and product quality control(原料及產品品質管制監控)

Product verification and validation(產品驗證作業)

Handling of incoming material issues(進料問題處理)

Analysis and resolution of supplier raw material abnormalities(供應商原物料異常分析處理)

Inspection of new products and incoming/outgoing shipments(新產品與進出貨檢驗)

  • Certifications

Certified Quality Engineer (CQE) (品質工程師)

Certified Quality Technician (CQT) (品質技術師)

  • Other Requirements

Experience with SEM, GC, LC, HPLC, and IR operation is a plus(熟悉SEM/GC/LC/HPLC/IR操作尤佳)

Proactive and has a keen eye for details (積極主動,對細節有敏銳的洞察力)

Resourceful, solution-oriented with creative problem-solving skills (足智多謀、以解決問題為導向,具有創造性解決問題的能力)

Excellent interpersonal skills, and able to collaborate across different functions (優秀的人際關係技巧,並能在不同職能間協同合作)

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